Rasagiline Sandoz

Package leaflet: Information for the user

Rasagilina Sandoz 1 mg tablets

Generic medicine
Please read all of this leaflet carefully before you start taking this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4. Contents of this leaflet:
  1. What Rasagilina Sandoz is and what it is used for
  2. What you need to know before taking Rasagilina Sandoz
  3. How to take Rasagilina Sandoz
  4. Possible side effects
  5. How to store Rasagilina Sandoz
  6. Contents of the pack and other information

1. What Rasagilina Sandoz is and what it is used for

Rasagilina Sandoz contains the active substance rasagilina and is used in the treatment of Parkinson's disease in adults. It can be used with or without levodopa (another medicine used to treat Parkinson's disease).
In Parkinson's disease, there is a loss of dopamine-producing cells in the brain. Dopamine is a chemical in the brain involved in the control of movement. Rasagilina Sandoz helps increase and maintain stable levels of dopamine in the brain.

2. What you need to know before taking Rasagilina Sandoz

Do not take Rasagilina Sandoz

• if you are allergic to rasagiline or to any of the other ingredients of this medicine (listed in section 6).
• if you have severe liver impairment.

Do not take the following medicines during treatment with Rasagilina Sandoz:

• monoamine oxidase inhibitors (MAOIs) (e.g. for the treatment of depression or Parkinson's disease, or used for any other indication), including over-the-counter medicines and natural products such as St. John’s wort.
• meperidine (a strong analgesic). You must wait at least 14 days after stopping treatment with Rasagilina Sandoz before starting treatment with MAOIs or meperidine.

Warnings and precautions
Talk to your doctor before taking Rasagilina Sandoz.

• If you have any liver problems
• Discuss with your doctor any suspicious skin changes. Inform your doctor if you, your family members, or caregivers notice that you are developing unusual behaviors that make you unable to resist the impulse, drive, or urge to carry out certain activities that may be harmful or dangerous to you or others. These behaviors are known as impulse control disorders. In patients taking rasagiline and/or other medicines used to treat Parkinson’s disease, behaviors such as compulsions, obsessive thoughts, gambling addiction, excessive spending, impulsive behaviors, and abnormally increased sexual desire or an increase in sexual thoughts or urges have been observed. Your doctor may need to adjust your dose or discontinue treatment (see section 4). Rasagilina Sandoz may cause drowsiness and may cause you to fall asleep suddenly during daytime activities, especially if you are taking other dopaminergic medicines (used to treat Parkinson’s disease). For further information, refer to section "Driving and use of machines".

Children and adolescents
There is no indication for the use of Rasagilina Sandoz in children and adolescents. Therefore, the use of Rasagilina Sandoz is not recommended in patients under 18 years of age.

Other medicines and Rasagilina Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking any of the following medicines:

• certain antidepressants (selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, tricyclic or tetracyclic antidepressants)
• the antibiotic ciprofloxacin used to treat infections
• dextromethorphan, a medicine used for cough
• sympathomimetics such as those found in eye drops, nasal and oral decongestants, and cold remedies containing ephedrine or pseudoephedrine. Avoid concomitant use of Rasagilina Sandoz and antidepressants containing fluoxetine or fluvoxamine. If you are starting treatment with Rasagilina Sandoz, you must wait at least five weeks after stopping treatment with fluoxetine. If you are starting treatment with fluoxetine or fluvoxamine, you must wait at least 14 days after stopping treatment with Rasagilina Sandoz. Inform your doctor or pharmacist if you are a smoker or intend to stop smoking. Smoking may reduce the amount of Rasagilina Sandoz in your blood.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Avoid taking Rasagilina Sandoz during pregnancy, as the effects of Rasagilina Sandoz on pregnancy and the fetus are unknown.

Driving and use of machinery
Ask your doctor for advice before driving or using machinery, as Parkinson’s disease itself and treatment with Rasagilina Sandoz may affect your ability to do so.
Rasagilina Sandoz may cause dizziness and drowsiness; it may also cause sudden episodes of falling asleep. This effect may be increased if you are taking other medicines for the symptoms of Parkinson’s disease, or if you are taking medicines that cause drowsiness, or if you drink alcohol while taking Rasagilina Sandoz. If you have previously experienced drowsiness and/or sudden onset of sleep episodes, or experience them while taking Rasagilina Sandoz, do not drive or operate machinery (see section 2).

Rasagilina Sandoz contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially ‘sodium-free’.

3. How to take Rasagilina Sandoz

Take this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The recommended dose of Rasagilina Sandoz is 1 tablet of 1 mg taken orally once daily.
Rasagilina Sandoz may be taken with or without food.
If you take more Rasagilina Sandoz than you should
If you think you have taken too many Rasagilina Sandoz tablets, contact your doctor or
pharmacist immediately. Take the Rasagilina Sandoz packaging/blister with you to show to the doctor or pharmacist.
Symptoms reported after overdose of Rasagilina Sandoz have included slightly
euphoric mood (a mild form of mania), extremely high blood pressure, and serotonin syndrome
(see section 4).
If you forget to take Rasagilina Sandoz
Do not take a double dose to make up for the missed dose. Take the next dose
as scheduled, at the usual time.
If you stop taking Rasagilina Sandoz
Do not stop treatment with Rasagilina Sandoz without first talking to your doctor.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if you notice any of the following symptoms. You may need
urgent medical advice or treatment:

• If you develop unusual behaviour such as compulsions, obsessive thoughts, gambling addiction, excessive shopping or spending, impulsive behaviour, abnormally increased sex drive or an increase in sexual thoughts (impulse control disorders) (see section 2).
• If you see or hear things that are not real (hallucinations).
• Any combination of hallucinations, fever, restlessness, tremor, and sweating (serotonin syndrome).
• If you notice suspicious skin changes, as patients with Parkinson's disease have an increased risk of skin cancer (not only melanoma) (see section 2).

Other side effects
Very common (may affect more than 1 in 10 people):

• involuntary movements (dyskinesia)
• headache.

Common (may affect up to 1 in 10 people):

• abdominal pain
• falls
• allergy
• fever
• flu-like illness (influenza)
• general feeling of being unwell (malaise)
• neck pain
• chest pain (angina pectoris)
• decrease in blood pressure upon standing, accompanied by symptoms such as dizziness or feeling faint (orthostatic hypotension)
• decreased appetite
• constipation
• dry mouth
• nausea and vomiting
• flatulence
• abnormal results in blood tests (leucopenia)
• joint pain (arthralgia)
• musculoskeletal pain
• inflammation of joints (arthritis)
• numbness and weakness of the hand muscle (carpal tunnel syndrome)
• loss of body weight
• abnormal dreams
• difficulty with muscle coordination (balance disorders)
• depression
• dizziness
• prolonged muscle contractions (dystonia)
• runny nose (rhinitis)
• skin irritation (dermatitis)
• rash
• red eyes (conjunctivitis)
• urinary urgency.

Uncommon (may affect up to 1 in 100 people):

• cerebrovascular stroke
• heart attack (myocardial infarction)
• blistering skin rash (vesiculobullous rash).

Not known: frequency cannot be estimated from the available data

• High blood pressure
• Excessive sleepiness
• Sudden onset of sleep

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rasagilina Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Rasagilina Sandoz contains

• The active substance is rasagilina. Each tablet contains 1 mg of rasagilina (as rasagilina tartrate).
• The other components are: microcrystalline cellulose, corn starch, pregelatinized starch (from corn), talc, sodium stearil fumarate.

Description of the appearance of Rasagilina Sandoz and contents of the pack
Rasagilina Sandoz tablets are white to off-white, round, flat, with bevelled edges (6.5 mm).
Pack sizes of 10, 28 and 30 tablets in blisters.
Not all pack sizes may be marketed.
Delorbis Pharmaceuticals LTD, 17 Athinon Street, Ergates Industrial Area,
2643 Ergates, Lefkosia, Cyprus
Iberfar – Indústria Farmacêutica, S.A., Rua Consiglieri Pedroso, no. 121-123 Queluz de Baixo,
Barcarena, Portugal
Sofarimex – Indústria Química e Farmacêutica, S.A., Av. das Indústrias – Alto do Colaride, Cacém,
Portugal
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, Sachsen-Anhalt, Barleben, Germany
Germany Rasagilin HEXAL 1 mg Tabletten
Austria Rasagilin 1 A Pharma 1 mg Tabletten
Italy Rasagilina Sandoz